Nucala
mepolizumab
Asthma
Date of authorisation:
Revision: 18
Last updated:
MedicineHumanAuthorised
EMEA-000069-PIP04-13-M02 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: P/0300/2018
Route(s) of administration: Subcutaneous use
Pharmaceutical form(s):
Powder for solution for injection or infusion
Solution for injection
Decision date:
Last updated:
Compliance check: ✔
PIPHuman
EMEA-000069-PIP01-07-M07 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Haematology-Hemostaseology
PIP number: P/0384/2020
Route(s) of administration: Subcutaneous use
Pharmaceutical form(s):
Powder for solution for infusion
Solution for injection in pre-filled syringe
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
EMEA-000069-PIP02-10-M08 - paediatric investigation plan
Decision type: PM: decision on the application for modification of an agreed PIP
Therapeutic area: Pneumology-allergology
PIP number: P/0239/2017
Route(s) of administration: Intravenous useSubcutaneous use
Pharmaceutical form(s):
Powder for solution for injection/infusion
Solution for injection
Decision date:
Last updated:
Compliance check: ✔
PIPHuman
EMEA-000069-PIP05-16 - paediatric investigation plan
Decision type: W: decision granting a waiver in all age groups for all conditions or indications
Therapeutic area: Pneumology-allergology
PIP number: P/0119/2017
Route(s) of administration: Subcutaneous use
Pharmaceutical form(s):
Solution for injection
Powder for solution for injection
Decision date:
Last updated:
Compliance check: ✖
PIPHuman
Quinolones - referral
enrofloxacin
marbofloxacin
danofloxacin mesilate
danofloxacin
flumequine
amoxicillin
difloxacin hydrochloride
oxolinic acid
Colistin sulfate
Amoxicillin trihydrate
difloxacin
bromhexine
oxytetracycline hydrochloride
Article 35
Status: European Commission final decision
Opinion/position date:
EC decision date:
Last updated:
ReferralVeterinary
Bosatria
mepolizumab
Date of withdrawal:
Last updated:
MedicineHumanWithdrawn application